Mintz Levin - Health Law & Policy Matters

OIG Finds Exclusive Lab Arrangement May Violate Anti-Kickback Statute

Yesterday the Office of Inspector General for the Department of Health and Human Services (the “OIG”) issued Advisory Opinion 15-04 (“Advisory Opinion”) in which it found that an exclusive arrangement between a laboratory and a…more
| Administrative Law, Health, Science, Computers, & Technology

$12.6 Million Sandoz ASP Reporting Settlement Raises More Questions Than It Answers

Recently, HHS-OIG announced a first-of-its-kind settlement over pharmaceutical manufacturer reporting of Average Sales Price (ASP). Sandoz, Inc. agreed to pay a civil monetary penalty of $12.64 million for alleged failure to…more
| Health, Science, Computers, & Technology, Government Contracting

Proposed Replacement of Sustainable Growth Rate Addresses Telehealth

On March 19th, Representative Michael C. Burgess, M.D. (R-TX) and Senate Finance Committee Chairman Orrin Hatch (R-UT) unveiled a bipartisan plan to repeal and replace the sustainable growth rate (SGR) physician payment system…more
| Health, Science, Computers, & Technology

Obama Administration Announces “Next Generation ACOs”

In a highly anticipated announcement on Tuesday, March 10, the Centers for Medicare and Medicaid Services (CMS) released details for a new Accountable Care Organization (ACO) program called the Next Generation ACO (NGACO). The…more
| Business Organizations, Elections & Politics, Health

Reported Compliance Problems: The Six Stages of Corporate Grief

Last week, I had the honor of participating in a panel discussion about how health care entities deal with reported compliance concerns at the ABA’s 16th Annual Conference on Emerging Issues in Healthcare Law. The panel was made…more
| Business Organizations, Health

GAO Report Highlights Improper Medicare/Medicaid Payments

Despite the efforts of the Department of Health and Human Services (HHS) to combat fraud and contain costs in federal healthcare programs, Medicare’s fee-for-service program (Parts A and B) and Medicaid were two of the top…more
| Health, Government Contracting

CMS Call Letter: Medicare Advantage Contracting Considerations

As a final addition to our series on the 2016 Draft Call Letter, we highlight some of the MA contracting issues raised by the Centers for Medicaid and Medicare Services (“CMS”). Specifically, CMS (1) recommends Medicare…more
| Health, Government Contracting

Mother Nature Axes 340B Hearing, But Written Testimony Survives

Mother Nature claimed another victim this week. The U.S. House of Representatives Energy and Commerce Subcommittee on Health was scheduled to hold a hearing on March 5, 2015 – Examining the 340B Drug Pricing Program. But with…more
| Elections & Politics, Health, Science, Computers, & Technology

CMS Call Letter: Provisions Related to Dual Eligible and Low Income Subsidy Individuals

For the last of our series on the 2016 Draft Call Letter, we focus on the provisions impacting plans serving Medicare-Medicaid, or dual eligible, enrollees. As we have previously posted, the Centers for Medicare & Medicaid…more
| Health

MA Risk Adjustment in the 2016 Call Letter and … in Health Care Fraud Charges

In past Call Letters, CMS has proposed and finalized significant changes to the Medicare Advantage risk adjustment system including, recalibrations, deletions and additions of diagnoses codes, and questioning of the value of…more
| Criminal Law, Health

CMS Call Letter: Pharmacy Network Implications

As part of our continuing series on CMS’s 2016 Call Letter, we take a closer look at the provisions in the Call Letter affecting PBM and plan sponsor pharmacy networks. In the Call Letter, CMS raises concerns about preferred…more
| Health, Science, Computers, & Technology

CMS Call Letter: Changes to and Implications of Star Ratings

In its February 20, 2015 Advance Notice of Methodological Changes for Calendar Year (CY) 2016 for Medicare Advantage Capitation Rates, Part C and Part D Payment Policies and 2016 Call Letter, CMS addressed a variety of issues…more
| Health

CMS Releases 2016 Draft Call Letter

Last week, the Centers for Medicare & Medicaid (CMS) released its 2016 Advance Rate Notice and draft Call Letter (2016 Call Letter) for the Medicare Advantage (MA) and Medicare Part D programs. The 2016 Call Letter outlines…more
| Health

Telehealth Bill Moving Forward in Florida-But Medicaid Coverage Sacrificed

Last week, the Florida Senate Health Policy Committee removed language from proposed telehealth legislation that would require Medicaid reimbursement for telemedicine services at the same rates as face-to-face examinations…more
| Communications & Media Law, Health, Science, Computers, & Technology

CMS Delays 60-Day Rule, But Overpayment Case Law Emerging

The Centers for Medicare & Medicaid Services (CMS) recently announced a one-year delay in finalizing the long-awaited and closely watched rule addressing the 60-day deadline to return Medicare and Medicaid overpayments (the…more
| Civil Remedies, Criminal Law, Health
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